Skip to main content
OpenTrials
Completed

NCT Number: NCT03384745

A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Dupnitsa, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects between 18 and 75 years of age.
  • Moderate to severe plaque-type psoriasis for at least 6 months.
  • Subject is a candidate for systemic biologic therapy.
  • Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
  • Subject is able to comply with the study procedures.
  • Subject must provide informed consent.

Exclusion criteria

(Main):

  • Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
  • Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
  • Laboratory abnormalities at screening, as defined in the study protocol.
  • Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
  • Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
  • History of suicidal thoughts within 12 months.

Treatment and study plan

M1095 (Sonelokimab)

Drug

M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Other names: Sonelokimab

Placebo

Drug

Placebo contains no active drug.

secukinumab

Drug

Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

Other names: Cosentyx®

Primary outcomes

  1. Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1

    Time frame: Week 12, as compared to Week 0 (baseline)

    The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

Secondary outcomes

  1. Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)

    Time frame: Week 12, as compared to Week 0 (baseline)

    PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.

  2. Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)

    Time frame: Week 12, as compared to baseline

    PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline

  3. Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)

    Time frame: Week 12, as compared to Week 0 (baseline)

    PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline

Sponsors and collaborators

Lead sponsor

Bond Avillion 2 Development LP

Industry

Collaborators

  • Avillion LLP

Registry information

Official study title

A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 27, 2017
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.